FREMONT, Calif., Aug. 28 /PRNewswire-FirstCall/ -- Vermillion, Inc. , formerly Ciphergen Biosystems, today announced the publication of research that details how a protein biomarker called beta-2 microglobulin may aid in the diagnosis of peripheral artery disease (PAD). The findings, which suggest beta-2 microglobulin is elevated in patients with PAD and that the level of the protein is correlated with the severity of the disease, will be published during September in Circulation and is currently online at http://circ.ahajournals.org/.
Working with scientists at Stanford University, Vermillion intends to develop a blood test for the diagnosis of PAD and the Company’s development program is aimed at identifying and commercializing a panel of novel biomarkers, which includes the newly discovered role of beta-2 microglobulin.
“Peripheral artery disease is a common disease, affecting approximately 10 million Americans. Unfortunately, PAD is commonly unrecognized in patients,” said John Cooke, MD, PhD, Professor of Medicine at Stanford University and senior author on the paper. “Patients with PAD are at high risk of heart and vessel complications unless they receive preventative treatment. A blood test would be useful to identify individuals who are at risk for the condition and triage them to further testing.”
Over 370 patients at risk of PAD were intensively studied using questionnaires, blood tests, treadmill exercise, limb blood pressures and coronary angiography. Proteomic profiling studies of the blood revealed a protein that was higher in patients with PAD. In subsequent studies, the protein was identified as beta-2 microglobulin.
Beta-2 microglobulin levels were correlated with the severity of disease, as determined by ankle blood pressures, and by the distance patients could walk on a treadmill. Beta 2microglobulin was an independent predictor, even after taking into consideration traditional risk factors such as cholesterol, diabetes, and age.
“This biomarker discovery may provide new insight into the pathophysiology of peripheral artery disease and may contribute towards the development of our panel of biomarkers to identify patients at risk for PAD,” said Eric T. Fung, M.D., Ph.D., Chief Scientific Officer for Vermillion. “We are engaged in final validation studies to determine an optimal cutoff that stratifies patients according to their likelihood of having peripheral artery disease.”
As part of a strategic alliance agreement, Vermillion and Quest Diagnostics are working closely together to expedite development and release of the PAD test.
About Peripheral Artery Disease (PAD)
PAD, a serious but often asymptomatic disorder affecting some eight to 12 million Americans, is caused by the buildup of fat and cholesterol, or plaque, in the peripheral arteries, disrupting normal blood flow. Left untreated, PAD more than doubles the risk of heart attack and stroke and increases the risk of amputation and death. There are treatments that can save the lives and limbs of these patients, once the disease is recognized.
About Vermillion’s Peripheral Artery Disease Program
Vermillion, in collaboration with Stanford University, is developing a blood-based assay for the detection of PAD. In January 2007, Quest Diagnostics accepted this program as the second of three diagnostic tests for joint development under their existing strategic alliance agreement.
About Vermillion, Inc.
Vermillion, Inc. (formerly Ciphergen Biosystems, Inc.) is dedicated to the discovery, development and commercialization of novel high-value diagnostic tests that help physicians diagnose, treat and improve outcomes for patients. Vermillion, along with its prestigious scientific collaborators, has ongoing diagnostic programs in oncology/hematology, cardiology and women’s health with an initial focus in ovarian cancer. Based in Fremont, California, more information about Vermillion can be found on the Web at http://www.vermillion.com.
Forward-Looking Statements
This news release contains forward-looking statements that involve significant risks and uncertainties, including those discussed below and others that can be found in Vermillion’s Form 10-K for the year ended Dec. 31, 2006, and in Vermillion’s periodic reports on Form 10-Q and Form 8-K. Vermillion is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
The scientific information discussed in this news release is preliminary and investigative. No forward-looking statement can be guaranteed and actual results may differ materially from those Vermillion projects. Discovery or identification of new protein biomarkers cannot be guaranteed and movement beyond the clinical validation process to a test that successfully screens patients for PAD is uncertain; consequently, there can be no guarantee that the identification of potential diagnostic markers will be successful or be an appropriate basis for a commercially available test for PAD.
Vermillion, Inc.
CONTACT: Sue Carruthers of Vermillion, Inc., +1-510-505-2233, or DarylMessinger of WeissComm Partners, +1-415-946-1062
Web site: http://www.vermillion.com/
